Traumatic Brain Injury
Conditions
Brief summary
1. Safety. The number of patients experiencing at least one serious adverse drug reaction (SADR). 2. Biological activity. a) The number of responder patients, defined as in paragraph ”Statistical design and sample size” b) The quantitative plasmatic NfL at Day 14 as measured by ultra-sensitive single-molecule array immunoassay (SIMOA). The plasmatic NfL levels, as well as all secondary outcomes, will be only analyzed if at least one of the treatment arms will be considered as safe.
Detailed description
1. Brain injury evolution and white matter damage by longitudinal advanced magnetic resonance imaging (MRI) (performed at 14 days +/- 3 days ,at 6 months +/- 15 days and 12 months +/- 15 days post-TBI)., 2. Brain immunomodulatory changes by temporal profiling of circulating biomarkers of: a) structural damage: NfL, glial fibrillary acidic protein (GFAP) b) neuroinflammation: interleukin-6 (IL-6), IL-10, tumor necrosis factor alpha (TNFα) c) vascular integrity: matrix metallopeptidase 9 (MMP-9), 3. Clinical outcome by a structured clinical and neuropsychological outcome assessment at both 6 and 12 months, by: a) Glasgow Outcome Scale Extended (GOSE) b) quality of life after brain injury (QOLIBRI) test
Interventions
DRUGMesenchymal stromal cells
Sponsors
Fondazione IRCCS San Gerardo Dei Tintori
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety. The number of patients experiencing at least one serious adverse drug reaction (SADR). 2. Biological activity. a) The number of responder patients, defined as in paragraph ”Statistical design and sample size” b) The quantitative plasmatic NfL at Day 14 as measured by ultra-sensitive single-molecule array immunoassay (SIMOA). The plasmatic NfL levels, as well as all secondary outcomes, will be only analyzed if at least one of the treatment arms will be considered as safe. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Brain injury evolution and white matter damage by longitudinal advanced magnetic resonance imaging (MRI) (performed at 14 days +/- 3 days ,at 6 months +/- 15 days and 12 months +/- 15 days post-TBI)., 2. Brain immunomodulatory changes by temporal profiling of circulating biomarkers of: a) structural damage: NfL, glial fibrillary acidic protein (GFAP) b) neuroinflammation: interleukin-6 (IL-6), IL-10, tumor necrosis factor alpha (TNFα) c) vascular integrity: matrix metallopeptidase 9 (MMP-9), 3. Clinical outcome by a structured clinical and neuropsychological outcome assessment at both 6 and 12 months, by: a) Glasgow Outcome Scale Extended (GOSE) b) quality of life after brain injury (QOLIBRI) test | — |
Countries
Italy
Outcome results
None listed